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Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

RecruitingPhase 3Ages 18 Years - anyAllFujian Shengdi Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female, able and willing to provide a written informed consent 2. Diagnosed with type 2 diabetes ≥ 90 days; 3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days; 4. HbA1c was 7.5%\~11.0% (both inclusive); 5. Body Mass Index (BMI) ≥22 kg/m2 at screening. Exclusion Criteria: 1. A history of type 1 diabetes, specific diabetes, or secondary diabetes; 2. Have a history of severe hypoglycemia within t180 days prior to screening; 3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening; 4. Have a history of malignancy within 5 years; 5. Known or suspected allergy or intolerance to the investigational medicinal products or related products; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.
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What it tests

  • HRS9531
  • HRS9531
  • Placebo
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Where

1 site
Perking University Peoples' Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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